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Primarily, when a compounding pharmacy creates a copy of an approved drug which is not subject to a shortage as determined by FDA, the compounder is no longer immune from the federal misbranding and unapproved new drug statutes, both of which could result in FDA enforcement and serious regulatory consequences

Emerging indications include metabolic dysfunction-associated steatohepatitis, where novel candidates are achieving statistically significant improvement with fibrosis improvement in studies

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